Arthritis, JuvenileDIGEST-JANCT06474546
Feasibility of a Diet Intervention for Juvenile Arthritis
A study testing Diet intervention in people with Arthritis, Juvenile and Arthritis, Childhood, run by The Hospital for Sick Children at 7 sites in Canada.
Trial summary
Families of children with arthritis are highly interested in the benefits of diet to improve their child's disease and future health outcomes. Previous research shows that the germs - bacteria and other organisms - that live in the intestines (gut microbiome) are important to how well immune systems work, and that… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Arthritis, Juvenile, Arthritis, Childhood, Juvenile Idiopathic Arthritis
- What is being tested?
- Diet intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 7 sitesCanada
- Study dates
- 7 Apr 2025to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 8-18 years
- Diagnosis of JIA (excluding systemic JIA, enthesitis-related arthritis, and rheumatoid factor (RF) positive polyarthritis) as per International League of Associations for Rheumatology (ILAR) criteria. (For this feasibility study, there will be no requirement for any particular level of disease activity.)
- Subjects on stable treatment - i.e., any medical treatment with disease-modifying antirheumatic drugs (DMARDs) and/or systemic or intraarticular corticosteroids, has been unchanged for 8 weeks, and is unlikely to change for 12 weeks as judged by the treating physician.
- Willingness to provide stool samples.
- English or French fluency adequate to answer the study questionnaires, and participate in diet instruction, as judged by the enrolling physician.
Who cannot join
- Documented specific food allergies, celiac disease.
- Co-morbidities that might impact the tolerability of the study diet, e.g., type I diabetes, peptic ulcer disease, etc.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Canada7 sites, 4 recruiting
- Recruiting
McMaster Children's Hospital
Hamilton, Ontario, L8N 3Z5
Tania Cellucci, MD, MScCH, FRCPC
Tania Cellucci, MD, MScCH, FRCPC
- Recruiting
London Health Sciences Centre
London, Ontario, N6A 5W9
Roberta Berard, MD, FRCPC, MSc
Roberta Berard, MD, FRCPC, MSc
- Recruiting
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, H3T 1C5
Jean Jacques De Bruycker, MD, FRCPC
Jean Jacques De Bruycker, MD, FRCPC
- Active, not recruiting
Children's Hospital of Eastern Ontario (CHEO)
Ottawa, Ontario, K1H 8L1
- Active, not recruiting
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8
- Active, not recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
- Recruiting
University of Manitoba
Winnipeg, Manitoba, R3E 3P4
Lily Lim, MBBS, MRCPCH, FRCPC, PhD
Lily Lim, MBBS, MRCPCH, FRCPC, PhD
About this study
Official title: The Role of Diet, as Mediated by the Gut Microbiome, on Childhood Arthritis Disease Activity: a Feasibility Intervention Study
Families of children with arthritis are highly interested in the benefits of diet to improve their child's disease and future health outcomes. Previous research shows that the germs - bacteria and other organisms - that live in the intestines (gut microbiome) are important to how well immune systems work, and that what people eat changes their gut microbiome. The investigators want to study whether a certain diet - based on the principles of the Mediterranean Diet - will improve arthritis for children and whether it was changes in the microbiome that led to improvement.
Fifty-four participants in this study will change their diet for an 8-week period, and will have the option of remaining on the diet for an additional 4 weeks. At three time points during the study (beginning, 8 weeks, and 12 weeks), participants will provide stool and blood samples, will complete questionnaires about diet and other aspects of lifestyle and health, and will complete a disease assessment by a clinician. From collecting all these samples and information, the investigators will be able to determine if the diet was successful in improving disease activity in children with arthritis and if the gut microbiome was changed as well.
This study will help the investigators figure out if a larger, and more definitive, study like this is possible to do in children with arthritis and will help the investigators design a bigger multinational study to confirm how diet affects disease outcomes and the microbiome in children with arthritis. If successful, this research will provide scientific knowledge to help families make their way through this difficult to- navigate topic.
- Being tested
- Diet intervention
- Keywords
- arthritis, diet, microbiome
- Medical subject headings
- Arthritis, Juvenile, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet interventionOther
A diet based on the principles of the Mediterranean Diet (MedDiet): consists of an abundance of plant foods - unrefined cereals, fruit, vegetables, and extra-virgin olive oil - a moderate consumption of poultry, dairy products, eggs, and low consumption of sweets and red meats.
All subjects will be instructed to follow the MedDiet for 8 weeks by the study team. Families will be given the option to continue for 12 weeks if they wish to do so.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Diet (MedDiet) Receives: Other: Diet intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Feasibility 1) Participant accrual rate:
The proportion of all subjects who are approached that enroll and the accrual frequency at each site.
Measured: 8-12 weeks
(Feasibility 2) The proportion of subjects who complete all the various measurement steps
Including return of the fecal samples, gender identification, completion rate of the food diary, etc.
The proportion of subjects who continue in the 12-week extension will be recorded.
Measured: 8-12 weeks
(Feasibility 3) Nutrient intake
Measured by the participants completing an ecologic momentary assessment (EMA) food diary and the corresponding Prospective Urban Rural Epidemiology (PURE) scores. The PURE score is calculated based on what the subjects entered in their EMA food diary. The score is from 0-6, with a higher score representing a healthier diet.
Measured: 8-12 weeks
(Feasibility 4) Adherence to the MedDiet
Measured by Mediterranean Diet Quality Index in children and adolescents (KIDMED) a questionnaire that measures adherence to the MedDiet scores. The index ranges from 0-12. The values are classified into three levels: > 8 is optimal MedDiet, 4-7 means improvement needed to adjust intake to MedDiet patterns, and ≤ 3 is low diet quality.
Measured: 8-12 weeks
(Feasibility 5) Tolerability of diet intervention
Tolerability will be measured by the Gastrointestinal Symptom Scale for Kids (GISSK), a well-validated and simple questionnaire, designed for use in juvenile idiopathic arthritis (JIA). There are 2 parts to the scale. A visual analog scale (VAS) from 0-100 where the higher score represents the higher severity of gastrointestinal symptoms. And a 8-part questionnaire that ranges from 0-8 where 0 represents no gastrointestinal symptoms.
Measured: 8-12 weeks
(Mediator 1) Changes in the microbiome
Measured by intestinal microbial ⍺-diversity (a measure representing the number of microbial groups and how evenly balanced they are within the gut), the individual species and functions of gut organisms (through shotgun metagenomics), and short chain fatty acids (SCFAs).
Measured: 8-12 weeks
(Mediator 2) Changes in juvenile arthritis disease activity score
Measured by the Juvenile Arthritis Disease Activity Scale (cJADAS10). This includes the 1) physician's global assessment of disease activity measured on a 10cm visual analog scale (VAS), (2) parent/patient's global assessment of well-being measured on a 10cm VAS, (3) count of joints with active disease up to 10 active joints. The total score ranges from 0-30 with higher number representing a higher juvenile arthritis disease activity score.
Measured: 8-12 weeks
(Mediator 3) Changes in functional status
Measured by the Childhood Health Assessment Questionnaire (CHAQ) (self/parent report scale that is widely used to measure functional status in children with arthritis). The score ranges from 0-3, with a 0 representing no functional disability and 3 representing severe disability.
Measured: 8-12 weeks
(Mediator 4) Changes in quality of life
Measured by the Quality of My Life (QoML) questionnaire (a validated questionnaire to measure well-being). QoML consists of 3 visual analog scales each scored out of 10. Higher scores indicate better quality of life.
Measured: 8-12 weeks
(Mediator 5) Changes in gut inflammation
Measured by fecal calprotectin.
Measured: 8-12 weeks
(Mediator 6) Changes in systemic inflammation
Measured by a blood biomarker panel, a composite measure of immune activation comprising 49 analytes:
(sCD40L, EGF, Eotaxin, FGF-2, Flt-3 ligand, Fractalkine, G-CSF, GM-CSF, GROα, IFNα2, IFNγ, IL-1α, IL-1β, IL-1ra, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12 (p40), IL-12 (p70), IL-13, IL-15, IL-17A, IL-17E/IL-25, IL-17F, IL-18, IL-22, IL-27, IP-10, MCP-1, MCP-3, M-CSF, MDC (CCL22), MIG, MIP-1α, MIP-1β, PDGF-AA, PDGF-AB/BB, RANTES, TGFα, TNFα, TNFβ, VEGF-A, YKL40)
Measured: 8-12 weeks
Secondary outcomes (7)
(Confounder 1) Sleep quality
Measured by FitBit accelerometry
Measured: 8-12 weeks
(Confounder 2) Patient-reported Sleep Quality
Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbances questionnaire. The total score ranges from 0-40 with a higher score representing a poor sleep quality.
Measured: 8-12 weeks
(Confounder 3) Physical activity
Measured by the Godin-Shephard Leisure-Time Physical Activity Questionnaire (GODIN) exercise questionnaire. A total score of 24 or more is active, 14 - 23 is moderately active, and less than 14 units is sedentary.
Measured: 8-12 weeks
(Confounder 4) Sex
Results will be stratified by sex at birth.
Measured: 8-12 weeks
(Confounder 5) Gender
Gender will be collected using the Perceived Similarity to Gender Groups Measure for children and youth.
Measured: 8-12 weeks
(Confounder 6) Medication use
Will be abstracted from the patient chart. Results will be stratified by medication use.
Measured: 8-12 weeks
(Confounder 7) Age
Stratify data by age group (8 - 12 and 13 - 18)
Measured: 8-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start7 Apr 2025
- Primary completionAug 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, JuvenileStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Brian M. Feldman, The Hospital for Sick Children
- Investigators
- Brian M. Feldman, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474546
- Sponsor's protocol ID
- 1000080845
- Acronym
- DIGEST-JA
- Status last verified
- Jul 2026
- First submitted
- 5 Jun 2024
- Last updated
- 29 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Diet, as Mediated by the Gut Microbiome, on Childhood Arthritis Disease Activity: a Feasibility Intervention Study
- ClinicalTrials.gov ID
- NCT06474546
- Acronym / sponsor ID
- DIGEST-JA / 1000080845
- Keywords
- arthritis, diet, microbiome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Families of children with arthritis are highly interested in the benefits of diet to improve their child's disease and future health outcomes. Previous research shows that the germs - bacteria and other organisms - that live in the intestines (gut microbiome) are important to how well immune systems work, and that what people eat changes their gut microbiome. The investigators want to study whether a certain diet - based on the principles of the Mediterranean Diet - will improve arthritis for children and whether it was changes in the microbiome that led to improvement.
Fifty-four participants in this study will change their diet for an 8-week period, and will have the option of remaining on the diet for an additional 4 weeks. At three time points during the study (beginning, 8 weeks, and 12 weeks), participants will provide stool and blood samples, will complete questionnaires about diet and other aspects of lifestyle and health, and will complete a disease assessment by a clinician. From collecting all these samples and information, the investigators will be able to determine if the diet was successful in improving disease activity in children with arthritis and if the gut microbiome was changed as well.
This study will help the investigators figure out if a larger, and more definitive, study like this is possible to do in children with arthritis and will help the investigators design a bigger multinational study to confirm how diet affects disease outcomes and the microbiome in children with arthritis. If successful, this research will provide scientific knowledge to help families make their way through this difficult to- navigate topic.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Diet interventionDiet (MedDiet) |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Ages 8-18 years
- Diagnosis of JIA (excluding systemic JIA, enthesitis-related arthritis, and rheumatoid factor (RF) positive polyarthritis) as per International League of Associations for Rheumatology (ILAR) criteria. (For this feasibility study, there will be no requirement for any particular level of disease activity.)
- Subjects on stable treatment - i.e., any medical treatment with disease-modifying antirheumatic drugs (DMARDs) and/or systemic or intraarticular corticosteroids, has been unchanged for 8 weeks, and is unlikely to change for 12 weeks as judged by the treating physician.
- Willingness to provide stool samples.
- English or French fluency adequate to answer the study questionnaires, and participate in diet instruction, as judged by the enrolling physician.
Key exclusion criteria (2 listed)
- Documented specific food allergies, celiac disease.
- Co-morbidities that might impact the tolerability of the study diet, e.g., type I diabetes, peptic ulcer disease, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet interventionA diet based on the principles of the Mediterranean Diet (MedDiet): consists of an abundance of plant foods - unrefined cereals, fruit, vegetables, and extra-virgin olive oil - a moderate consumption of poultry, dairy products, eggs, and low consumption of sweets and red meats. All subjects will be instructed to follow the MedDiet for 8 weeks by the study team. Families will be given the option to continue for 12 weeks if they wish to do so. | Other | Intervention |
Primary outcome
(Feasibility 1) Participant accrual rate:
Time frame: 8-12 weeks
The proportion of all subjects who are approached that enroll and the accrual frequency at each site.
(Feasibility 2) The proportion of subjects who complete all the various measurement steps
Time frame: 8-12 weeks
Including return of the fecal samples, gender identification, completion rate of the food diary, etc. The proportion of subjects who continue in the 12-week extension will be recorded.
(Feasibility 3) Nutrient intake
Time frame: 8-12 weeks
Measured by the participants completing an ecologic momentary assessment (EMA) food diary and the corresponding Prospective Urban Rural Epidemiology (PURE) scores. The PURE score is calculated based on what the subjects entered in their EMA food diary. The score is from 0-6, with a higher score representing a healthier diet.
(Feasibility 4) Adherence to the MedDiet
Time frame: 8-12 weeks
Measured by Mediterranean Diet Quality Index in children and adolescents (KIDMED) a questionnaire that measures adherence to the MedDiet scores. The index ranges from 0-12. The values are classified into three levels: > 8 is optimal MedDiet, 4-7 means improvement needed to adjust intake to MedDiet patterns, and ≤ 3 is low diet quality.
(Feasibility 5) Tolerability of diet intervention
Time frame: 8-12 weeks
Tolerability will be measured by the Gastrointestinal Symptom Scale for Kids (GISSK), a well-validated and simple questionnaire, designed for use in juvenile idiopathic arthritis (JIA). There are 2 parts to the scale. A visual analog scale (VAS) from 0-100 where the higher score represents the higher severity of gastrointestinal symptoms. And a 8-part questionnaire that ranges from 0-8 where 0 represents no gastrointestinal symptoms.
(Mediator 1) Changes in the microbiome
Time frame: 8-12 weeks
Measured by intestinal microbial ⍺-diversity (a measure representing the number of microbial groups and how evenly balanced they are within the gut), the individual species and functions of gut organisms (through shotgun metagenomics), and short chain fatty acids (SCFAs).
(Mediator 2) Changes in juvenile arthritis disease activity score
Time frame: 8-12 weeks
Measured by the Juvenile Arthritis Disease Activity Scale (cJADAS10). This includes the 1) physician's global assessment of disease activity measured on a 10cm visual analog scale (VAS), (2) parent/patient's global assessment of well-being measured on a 10cm VAS, (3) count of joints with active disease up to 10 active joints. The total score ranges from 0-30 with higher number representing a higher juvenile arthritis disease activity score.
(Mediator 3) Changes in functional status
Time frame: 8-12 weeks
Measured by the Childhood Health Assessment Questionnaire (CHAQ) (self/parent report scale that is widely used to measure functional status in children with arthritis). The score ranges from 0-3, with a 0 representing no functional disability and 3 representing severe disability.
(Mediator 4) Changes in quality of life
Time frame: 8-12 weeks
Measured by the Quality of My Life (QoML) questionnaire (a validated questionnaire to measure well-being). QoML consists of 3 visual analog scales each scored out of 10. Higher scores indicate better quality of life.
(Mediator 5) Changes in gut inflammation
Time frame: 8-12 weeks
Measured by fecal calprotectin.
(Mediator 6) Changes in systemic inflammation
Time frame: 8-12 weeks
Measured by a blood biomarker panel, a composite measure of immune activation comprising 49 analytes: (sCD40L, EGF, Eotaxin, FGF-2, Flt-3 ligand, Fractalkine, G-CSF, GM-CSF, GROα, IFNα2, IFNγ, IL-1α, IL-1β, IL-1ra, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12 (p40), IL-12 (p70), IL-13, IL-15, IL-17A, IL-17E/IL-25, IL-17F, IL-18, IL-22, IL-27, IP-10, MCP-1, MCP-3, M-CSF, MDC (CCL22), MIG, MIP-1α, MIP-1β, PDGF-AA, PDGF-AB/BB, RANTES, TGFα, TNFα, TNFβ, VEGF-A, YKL40)
7 secondary outcomes
(Confounder 1) Sleep quality
Time frame: 8-12 weeks
(Confounder 2) Patient-reported Sleep Quality
Time frame: 8-12 weeks
(Confounder 3) Physical activity
Time frame: 8-12 weeks
(Confounder 4) Sex
Time frame: 8-12 weeks
(Confounder 5) Gender
Time frame: 8-12 weeks
(Confounder 6) Medication use
Time frame: 8-12 weeks
(Confounder 7) Age
Time frame: 8-12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brian M. Feldman principal investigator
The Hospital for Sick Children
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet intervention in people with Arthritis, Juvenile and Arthritis, Childhood, run by The Hospital for Sick Children at 7 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hayyah Clairman (416-813-7979, hayyah.clairman@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(Feasibility 1) Participant accrual rate: (time frame: 8-12 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.